MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0620CSFMX
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).The returned device was inspected in our quality laboratory.During our analysis: we noted the microcatheter and snare associated with the coil system were returned; we noted the implant coil was found detached from the delivery pusher and tangled within the snare; we noted the microcatheter was returned with hub cut off of the proximal end; we noted no signs of a detachment cycle performed at the detachment zone; we observed dry blood within the pet jacket at the detachment zone; we observed the implant coil to be severely stretched and kinked throughout with minimal unstretched portions; we observed a complete break of the body coil 16cm distal from the body coil to hypotube weld (description indicated delivery pusher was cut); we noted the distal end of the broken body coil was retracted from the microcatheter with no resistance felt; we observed the sr thread to still be connected to the implant coil with the sr thread opaque in color at the implant coil proximal tip; we observed the distal end of the returned microcatheter to be formed into a "wave-like" shape.Root cause of the premature detachment endured by the coil system can likely be attributed to an overload of tensile stress endured by the sr thread.Upon return of the device, the implant coil was observed to be detached from its delivery pusher and to be severely stretched and kinked throughout.The implant coil was returned tangled within the snare used during the procedure.Further implant analysis showed the proximal tip to have a portion of the broken sr thread protruding from the implant coil with the thread being opaque in color, indicating the thread had endured an overload in tensile stress.Moreover, the body coil was found to have endured a complete fracture 16cm distal of the body coil to hypotube weld, which it was indicated in the description that the delivery pusher was cut.The exact cause of the tensile stress endured by the implant coil leading to the premature detachment could not be accurately identified.If the implant coil were to have become damaged during the attempts to reposition the coil, this could have caused friction leading to the detachment - however due to the damaged state of the returned implant this hypothesis could not be confirmed.The distal end of the microcatheter was found to take a "wave-like" shape, however the exact timing of when this damage occurred is unknown.If the damage to the microcatheter was sustained during the procedure, this could have led to the detachment of the implant coil.Additional testing of the microcatheter could not be performed due to its damaged state.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f230100130 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "during the coiling of a ruptured opthalmic aneurysm, the physician had a premature detachment of an optimax 6x20 coil today.The physician initially framed the aneurysm successfully with an optimax 8x30.On the deployment of his second coil an optimax 6x20, the physician noted he felt a pop about half way through the deployment and lost one to one.He had to snare the coil and remove.No patient injury occured.Coil and pusher are available for return." 02mar2023, additional information provided by issuer: " was the anatomy tortuous? mild.Was friction experienced during the advancement of the 6x20 coil, or even by the 8x30 coil? the physician said there was no resistance encountered when advancing the 8x30.He reported that he had little resistance with 6x20 but noted that his microcatheter kicked back multiple times and he was manipulating catheter and coil to reposition.Can you please confirm my understanding when reported "halfway through the deployment": the pop was experienced during implant transfer from microcatheter tip to treatment site.The implant coil was stent retrieved with a portion of the implant deployed from the microcatheter tip? after having to repositioning the microcatheter multiple times due to kickback over the optimax 6x20 coil system, reported that over half of the coil was eventually deployed within the initial 8x20 frame and did not like the position of the coil.Upon repositioning pulling back on the 6x20 coil the physician said he felt a "pop" and lost one to one with delivery wire and coil.He tried to use pusher wire to advance coil but his microcatheter unseated and kicked back out into ica and he had coil beyond the tip of microcatheter.He reported that he then cut back end of microcatheter and coil delivery wire to bring up a snare to remove coil.Is the microcatheter used during the procedure available for analysis? microcatheter is being returned with coil.It looks as though snare was included as well.Tech reported that the microcatheter used was a headway 90 degree tip.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 16627704
• Report Number: 3014162263-2023-00008
• Device Sequence Number: 4474577
• Product Code: HCG
• UDI-Device Identifier: 00818053025211
• UDI-Public: 00818053025211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI0620CSFMX
• Device Catalogue Number: N/A
• Device Lot Number: F230100130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown